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PARP Inhibitors Market to Register Immense Growth by 2034 Owing to Wider Opportunity in Multiple Indications with HRR (BRCA) Gene Mutations and Increasing Cost of Therapy of Leading PARP Inhibitors in the US | DelveInsight

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16 Oct, 2024, 21:31 GMT

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The PARP inhibitors market is anticipated to experience substantial growth in the coming years. This growth is driven by label expansion of leading PARP inhibitors in various indications, a rising number of cancer diagnoses mainly metastatic breast, ovarian, prostate, and pancreatic cancers, heightened awareness of HRR gene mutation testing (mainly BRCA mutation testing ), along with an evolving pipeline of newer treatments.

LAS VEGAS, Oct. 16, 2024 /PRNewswire/ -- DelveInsight's PARP Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging PARP inhibitors, market share of individual therapies, and current and forecasted PARP inhibitors market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Takeaways from the PARP Inhibitors Market Report

  • As per DelveInsight's analysis, the total market size of PARP inhibitors in the 7MM is expected to surge significantly by 2034.
  • First runner, LYNPARZA drew attention by treating patients with specific genetic mutations. LYNPARZA generated approximately USD 2.7 billion in revenue globally with approximately 40% revenue from the United States due to growth in usage in breast, ovarian, and prostate cancers.
  • In fact, AstraZeneca LYNPARZA is the most preferred and leading PARP inhibitor used widely in later lines of treatment, whereas RUBRACA has witnessed a downfall owing to the class scrutiny in ovarian cancer patients in 2022 and the bankruptcy of Clovis oncology in 2023. Within the prostate cancer space, we expect competition among PARP inhibitors in 1st line with AKEEGA, TALZENNA, and LYNPARZA receiving approval at the same time, however, AKEEGA's label has been restricted with a BRCA mutation only as compared to the entire HRR gene mutation for LYNPARZA and TALZENNA.
  • Despite growing competition, blockbuster LYNPARZA is set to remain on top in the PARP space. Following its first approval in chemo-treated (third line and above) ovarian cancer patients back in 2014, its label eventually expanded to breast, prostate, and pancreatic too. Most of LYNPARZA's revenue comes from ovarian and breast cancer. 
  • As LYNPARZA gets closer to its patent expiry in 2028 in the US, Astrazeneca is gearing up with its another PARP inhibitor, Saruparib (PARP1) in various indications with metastatic hormone-sensitive prostate cancer (mHSPC) being on top priority (Phase III trial ongoing).
  • Following LYNPARZA, another leading player is GSK's (originally developed by Tesaro) blockbuster, ZEJULA, which received its first approval in Ovarian Cancer in 2017. Out of all the PARP inhibitors, Clovis Oncology's RUBRACA had walked the hardest path as it never gained momentum since its first approval in 2016 along with a strict class-related scrutiny by the FDA in 2022, and bankruptcy of the company. This class scrutiny also affected other PARP inhibitors (such as LYNPARZA and ZEJULA) in later-line ovarian cancer patients.
  • Janssen's AKEEGA and Pfizer's TALZENNA are one of the most recent approvals (in 2023) in first-line metastatic castration-resistant prostate cancer (mCRPC) patients although TALZENNA was first approved in breast cancer patients with BRCA mutations in 2018. Even though TALZENNA's efficacy proves significant benefit in prostate cancer patients as per the FDA, the UK's NICE does not recommend it.
  • LeadingPARP inhibitor companies with their therapies already available on the market are  AstraZeneca/Merck Janssen, Pfizer/Astellas, GSK, Pharma& Schweiz, whereas emerging players evaluating  PARP inhibitors in various clinical trials in multiple indications include AtlasMedx, AbbVie, BeiGene, Allarity Therapeutics, Jiangsu Hengrui Pharmaceuticals and others Some of the key PARP inhibitors in the pipeline include AZD5305, AMXI-5001, Veliparib, and others. 

Discover which therapies are expected to grab the PARP inhibitors market share @ PARP Inhibitors Market Report

PARP Inhibitors Market Dynamics

The PARP inhibitors market has seen significant growth and transformation in recent years, driven primarily by advancements in oncology and the increasing recognition of these drugs' therapeutic potential. One of the key dynamics in the PARP inhibitors market is the increasing prevalence of cancer and the growing demand for targeted therapies. As the global incidence of cancer rises, there is a significant push towards more personalized and effective treatment options. PARP inhibitors have shown promise in clinical trials for various cancers beyond those with BRCA mutations, including pancreatic and non-small cell lung cancers, which broadens their market potential. This expansion into new indications enhances the overall market opportunity and drives further research and development.

Moreover, the competitive landscape is evolving as pharmaceutical companies invest heavily in the development of next-generation PARP inhibitors. Companies are not only working on improving the efficacy and safety profiles of existing drugs but are also exploring combination therapies that could enhance treatment outcomes. Strategic partnerships, mergers, and acquisitions in the industry are contributing to rapid advancements and commercialization of new products, which in turn affects market dynamics.

Additionally, regulatory pathways and reimbursement policies play a crucial role in shaping the market. The approval process for new therapies can be lengthy and complex, and regulatory bodies' decisions significantly impact market entry and adoption. Furthermore, the level of insurance coverage and reimbursement for PARP inhibitors influences their accessibility and affordability, impacting market growth. As policies evolve and more data becomes available, these factors will continue to influence the market's trajectory.

PARP Inhibitors Treatment Market 

So far, the approved PARP inhibitors are LYNPARZA (olaparib), TALZENNA (talazoparib), ZEJULA (niraparib), and RUBRACA (rucaparib), with LYNPARZA currently leading the market. PARP inhibitor monotherapy has been a breakthrough in treating many BRCA1/2-mutated cancers, providing both patients and doctors with promising treatment options. Research continues into alternative therapeutic pathways for PARP inhibitors, as well as understanding the mechanisms behind sensitivity and resistance. Identifying biomarkers is crucial for determining which patients will benefit most since while these treatments are effective in tumors with BRCA1/2 mutations or HRD, reliable HR-proficient markers are still needed.

GSK's decision to restrict ZEJULA's use in the US to only patients with germline BRCA mutations, while withdrawing its approval for late-line ovarian cancer, could have far-reaching consequences in the PARP inhibitor market. This move might impact other PARP inhibitors, such as LYNPARZA by AstraZeneca and Merck, and RUBRACA by Clovis Oncology.

Currently, RUBRACA's main revenue comes from its use as a second-line maintenance treatment for ovarian cancer. Any restrictions on this indication could significantly heighten Clovis's risk of bankruptcy. TALZENNA is emerging as a potential competitor to established PARP inhibitors like LYNPARZA and ZEJULA, thanks to promising clinical trial results. Its effectiveness in treating mCRPC may also benefit from its combination with Xtandi, a leading prostate cancer treatment.

Learn more about the FDA-approved PARP inhibitors @ PARP Inhibitors Drugs

Key Emerging PARP Inhibitors and Companies

Several key players, including AstraZeneca, Allarity Therapeutics, AtlasMedx, BeiGene, and others, are involved in developing drugs for PARP inhibitors for various indications such as ovarian cancer, breast cancer, prostate cancer, pancreatic cancer, and others.

Saruparib (AZD5305), a next-generation PARP1-selective inhibitor, is being tested in patients with tumors that have specific homologous recombination repair gene mutations. This drug is designed to precisely target PARP1, disrupting cancer cells by interfering with their DNA damage repair mechanisms. This strategy may enable PARP inhibitors to be used in new therapeutic settings and to be combined with other agents that activate DNA damage pathways, such as ADCs. 

Saruparib (AZD5305) is advancing towards potential registrational trials for prostate cancer, in combination with new hormonal therapies, with studies showing good tolerability at higher doses. The drug is currently being evaluated in clinical trials for patients with advanced solid tumors, including ovarian, breast, prostate, and pancreatic cancers.

Veliparib (ABT-888) is an experimental anti-cancer drug that functions as a PARP inhibitor. It works by blocking the PARP protein, which disrupts the repair of DNA damage in cancer cells, potentially increasing their vulnerability to anticancer therapies. Veliparib inhibits both PARP1 and PARP2, leading to synthetic lethality. The drug is currently under investigation for its effectiveness in treating solid tumors.

The anticipated launch of these emerging therapies are poised to transform the PARP inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the PARP inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

To know more about PARP inhibitors clinical trials, visit @ PARP Inhibitors Treatment Drugs 

PARP Inhibitors Overview

PARP inhibitors are a class of drugs that target the enzyme Poly (ADP-ribose) polymerase (PARP), which plays a crucial role in DNA repair processes, particularly in repairing single-strand breaks. By inhibiting PARP, these drugs prevent the repair of damaged DNA, leading to the accumulation of DNA breaks, which eventually causes cancer cells to die. This mechanism is particularly effective in tumors with deficiencies in other DNA repair pathways, such as those with BRCA1 or BRCA2 mutations, making PARP inhibitors a powerful targeted therapy for certain types of cancers, including ovarian, breast, and prostate cancers.

One of the key advantages of PARP inhibitors is their ability to selectively target cancer cells while sparing normal cells, reducing some of the side effects associated with traditional chemotherapy. However, like many targeted therapies, resistance to PARP inhibitors can develop over time, posing challenges for long-term treatment efficacy. Despite this, ongoing research is exploring combination therapies and new strategies to overcome resistance, further expanding the potential of PARP inhibitors in cancer treatment.

PARP Inhibitors Epidemiology Segmentation

The total incident cases of breast cancer in the US comprised approximately 297,000 cases in 2023. In 2023, in the United States, the total cases of metastatic castration-sensitive prostate cancer and metastatic castration-resistant prostate cancer were around 54,200 and 66,200, respectively.

The PARP inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

  • Total Incident Cases in Selected Indications for PARP Inhibitors
  • Total Eligible Patient Pool for PARP Inhibitors in Selected Indications 
  • Total Treated Cases in Selected Indications for PARP Inhibitors 

PARP Inhibitors Report Metrics

Details

Study Period

2020–2034

PARP Inhibitors Report Coverage

7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]

Key PARP Inhibitors Companies

AstraZeneca/Merck, Janssen, Pfizer/Astellas, Pharma& Schweiz, AtlasMedx, AbbVie, GlaxoSmithKline, Pfizer, BeiGene, Allarity Therapeutics, and others

Key PARP Inhibitors

LYNPARZA, ZEJULA, RUBRACA, TALZENNA, AKEEGA, Saruparib (AZD5305), AMXI-5001, Veliparib and others

Scope of the PARP Inhibitors Market Report

  • PARP Inhibitors Therapeutic Assessment: PARP Inhibitors current marketed and emerging therapies
  • PARP Inhibitors Market Dynamics: Conjoint Analysis of Emerging PARP Inhibitors Drugs
  • Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
  • Unmet Needs, KOL's views, Analyst's views, PARP Inhibitors Market Access and Reimbursement

Discover more about PARP inhibitors in development @ PARP Inhibitors Clinical Trials

Table of Contents

1

Key Insights

2

Report Introduction

3

Executive Summary of PARP Inhibitors

4

Key Events

5

Epidemiology and Market Forecast Methodology

6

PARP Inhibitors Market Overview at a Glance in the 7MM

6.1

Market Share (%) Distribution by Indication in 2023

6.2

Market Share (%) Distribution by Indication in 2034

7

PARP Inhibitors: Background and Overview

7.1

Introduction

7.2

Types of PARP inhibitors

7.3

Treatment

8

Target Patient Pool

8.1

Key Findings

8.2

Assumptions and Rationale: 7MM

8.3

Epidemiology Scenario in the 7MM

8.3.1

Total Incident Cases in Selected Indications for PARP Inhibitors in the 7MM

8.3.2

Total Eligible Patient Pool for PARP Inhibitors in Selected Indications in the 7MM

8.3.3

Total Treated Cases in Selected Indications for PARP Inhibitors in the 7MM

9

Marketed Therapies

9.1

Key Competitors

9.2

LYNPARZA: AstraZeneca

9.2.1

Product description

9.2.2

Regulatory milestones

9.2.3

Other developmental activities

9.2.4

Clinical development

9.2.5

Safety and efficacy

9.3

ZEJULA: GlaxoSmithKline

9.3.1

Product description

9.3.2

Regulatory milestones

9.3.3

Other developmental activities

9.3.4

Clinical development

9.3.5

Safety and efficacy

9.4

RUBRACA: Pharma& Schweiz GmbH 

9.4.1

Product description

9.4.2

Regulatory milestones

9.4.3

Other developmental activities

9.4.4

Clinical development

9.4.5

Safety and efficacy

9.5

TALZENNA: Pfizer

9.5.1

Product description

9.5.2

Regulatory milestones

9.5.3

Other developmental activities

9.5.4

Clinical development

9.5.5

Safety and efficacy

List to be continued in the report

10

Emerging Therapies

10.1

Key Competitors

10.2

AZD5305: AstraZeneca

10.2.1

Product description

10.2.2

Other developmental activities

10.2.3

Clinical development

10.2.4

Safety and efficacy

10.3

Veliparib: AbbVie

10.3.1

Product description

10.3.2

Other developmental activities

10.3.3

Clinical development

10.3.4

Safety and efficacy

List to be continued in the report

11

PARP Inhibitors: Seven Major Market Analysis

11.1

Key Findings

11.2

Market Outlook

11.3

Key Market Forecast Assumptions

11.3.1 

Cost Assumptions and Rebates

11.3.2

 Pricing Trends

11.3.3

Analogue Assessment

11.3.4 

Launch Year and Therapy Uptakes

11.4

Total Market Size by Indication in the 7MM

11.5

Total Market Size by Therapies in the 7MM

11.6

The United States Market Size

11.6.1

Total Market Size  by Indication in the United States

11.6.2

Total Market Size by Therapies in the United States

11.7

EU4 and the UK Market Size

11.7.1

Total Market Size by Indication in EU4 and the UK

11.7.2

Total Market Size by Therapies in EU4 and the UK

11.8

Japan Market Size

11.8.1

Total Market Size by Indication in Japan

11.8.2

Total Market Size by Therapies in Japan

12

Market Access and Reimbursement

13

SWOT Analysis

14

KOL Views

15

Unmet Needs

16

Appendix

16.1

Bibliography

16.2

Report Methodology

17

DelveInsight Capabilities

18

Disclaimer

19

About DelveInsight

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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